Bile Duct Cancer, Cholangiocarcinoma, Klatskin Tumor, Liver Cancer
Conditions
Keywords
Radiofrequency ablation, Intraductal, Biliary, Endoscopic retrograde cholangiography, Transpapillary, Stent dysfunction, Cholangitis, Obstruction
Brief summary
The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are: * Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)? * Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).
Interventions
PROCEDUREIntraductal biliary radiofrequency ablation
Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT) 2. Written informed consent 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Age ≥18 years 5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT 6. No prior radiofrequency ablation (RFA) for CCA 7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months) 8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first event, ie stent dysfunction | 6 months | • Time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin \>5 mg/dl and/or cholangitis (fever \>38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent Endpoint Review Committee \[ERC\].) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 30 month | Time to death or last seen alive |
| Satisfaction assessed by EORTC QLQ-C30 questionnaire | 6 months | The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in cancer patients. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Satisfaction assessed by EORTC QLQ-BIL21 questionnaire | 6 months | The EORTC QLQ-BIL21 consists of 21 questions: 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, in addition to 18 items grouped into 5 proposed scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). The response format is a four-point Likert scale.and designed to more specifically adress side effects. A high scale score represents a higher response level. |
| Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5 | 6 months | Safety events |
| Clinical event rate at 6 months | 6 months | Rate of clinical events defined as per primary outcome after 6 months follow up |
| Total days of overnight-hospital-stays | 6 months | Total days of overnight-hospital-stays |
Countries
Germany
Contacts
CONTACTProject Manager
PRINCIPAL_INVESTIGATORJohann von Felden, MD
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed